INTERVENTIONAL VASCULAR DIAGNOSTICS AND THERAPY. SeQuent Please OTW PERIPHERAL DRUG COATED BALLOON CATHETER
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1 INTERVENTIONAL VASCULAR DIAGNOSTICS AND THERAPY SeQuent Please OTW PERIPHERAL DRUG COATED BALLOON CATHETER
2 SeQuent Please OTW PERIPHERAL DRUG COATED BALLOON CATHETER The next level in treating peripheral stenoses Following a path of sustained research and development in drug coated balloons SeQuent Please OTW offers significant improvements in peripheral angioplasty.¹ DCB TREATMENT FOR ABOVE AND BELOW THE KNEE Leave nothing behind Effective and homogenous drug delivery into the vessel wall Long-term efficacy with short-term drug release Keep all therapeutical options No stent related complications Paclitaxel with an effective drug dose of 3µg/mm² 2 ¹ A Tepe, G. et al. Cardiovasc Intervent Radiol (2017). doi: /s ² standard dose (3.0-µg and 3.5µq) PCBs were significantly more effective compared with low-dose 2µg PCB in reducing both restenosis [ ] and TLR [ ]. Katsanos K et al. in J Endovasc Ther Apr;23(2): ³ Ciccone G et al. in Curr Med Chem. 2013;20(10): ⁴ Magyar K et al. Clin Hemorheol Microcirc. 2012;50(3): Effective drug dose in comparison to DCB with lower drug concentration² Homogeneous coating even in the balloon folds
3 A fruitful formulation: Paclitaxel & Resveratrol SeQuent Please OTW with its optimized and clinically proven¹ coating technology is made to facilitate easy and effective DCB use in daily practice. Resveratrol as excipient with positive characteristics Consistent crystalline coating for your daily routine⁵ Naturally occurring, plant based substance High mechanical resistance of the coating Anti-inflammatory, antioxidant & antihypertensive³,⁴ Low drug loss in simulated use (<2%) Highly available drug dose after inflation Enables drug transfer into vessel wall ⁵ Data on file at B.Braun 3
4 SeQuent Please OTW PERIPHERAL DRUG COATED BALLOON CATHETER CONSEQUENT Randomized Controlled Trial⁶ Study design & characteristics 153 patients Rutherford II-IV (95% Grade III-IV) Pre-procedure diameter stenosis: 76.6 % (±18.1) TASC C+D lesions: 23.5 % Mean lesion length: 13.2 cm (±10.4) Positive Remodeling (LLL <0.00mm) DCB group: 35.2 % Predilatation: 55.6 % Bailout stenting: 16.3 % Mean lesion length 13.2 cm CONSEQUENT ILLUMENATE FIH8 PACIFIER9 LEVANT I10 BIOLUX P-I11 4 ⁶ Tepe, G. et al. Cardiovasc Intervent Radiol (2017). doi: /s ⁷ Predilatation was only mandatory in total occlusions and even long & complex lesions were treated. ⁸ Schroder H Catheterization and Cardiovascular Interventions, Volume 86, Issue 2 August 2015 Pages ⁹ Werk M et al. Circ Cardiovasc Interv. 2012;5(6): Scheinert D et al. JACC Cardiovasc Interv. 2014;7(1): ¹1 Zeller T et al. JACC Cardiovasc Interv. 2015;8(12):
5 The safety and efficacy of SeQuent Please OTW was investigated in real world conditions.⁷ Improving patients quality of life The CONSEQUENT randomized controlled trial demonstrated outstanding quality of life improvements for patients treated with SeQuent Please OTW. 6 month late lumen loss (LLL) p = POBA DCB mm month TLR rate 37.7 POBA p = DCB % 12 month mean walking distance p = POBA DCB m 5
6 SeQuent Please OTW PRODUCT PORTFOLIO AND SPECIFICATIONS SeQuent Please OTW 035 Shaft length 75 cm Shaft length 130 cm Balloon diameter (mm) Balloon length (mm) Sheath compatibility (F) Nominal pressure (atm) Rated burst pressure (atm) SeQuent Please OTW 014 Shaft length 130 cm Balloon diameter (mm) Balloon length (mm) Sheath compatibility (F) Nominal pressure (atm) Rated burst pressure (atm) Technical specifications Catheter type OTW Shaft profile 035: 4.9F 5.4F 014: 2.5F 3.6F Lesion entry profile 035: : Radiopaque markers 2 markers (Platinum/Iridium) Coating Drug: Paclitaxel (concentration 3 µg/mm²) Excipient: Resveratrol (plant based substance acts as hydrophilic spacer) Homogeneous coating even in the balloon folds exceeding distal and proximal markers Duration of inflated balloon: 30 seconds 6
7 B. Braun Vascular Systems PORTFOLIO FOR PERIPHERAL DIAGNOSTICS AND THERAPY Angiodyn Procedure Kits Celsite Access Port Systems Vascular Implants 7
8 Distributor B. Braun Melsungen AG Vascular Systems Sieversufer Berlin Germany Phone Fax Manufacturer acc. to MDD 93/42EG B. Braun Melsungen AG Carl-Braun-Str Melsungen Germany The product trademarks SeQuent, VascuFlex, Angiodyn and Celsite are registered trademarks of B. Braun Melsungen AG. Subject to technical changes. All rights reserved. This brochure may only be used for the exclusive purpose of obtaining information about our products. Reproduction in any form partial or otherwise is not permitted /1.0/2
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